Impurity reference standards
Sitagliptin impurities & reference standards
Characterised Sitagliptin impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
111reference materials
1isotope-labelled
COAHPLC · NMR · MS on request
Parent API: Sitagliptin
486460-32-6 · C16H15F6N5O
tert-Butyl (R)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoate
- CAS
- 1246961-45-4
- Formula
- C19H26F3NO4
- MW
- 389.4 g/mol
VQ-044682
![Tert-Butyl 3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazine-7(8H)-carboxylate chemical structure](/media/structures/XXHCMRQBGHYJBX-UHFFFAOYSA-N.svg)
Tert-Butyl 3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazine-7(8H)-carboxylate
- CAS
- 877402-43-2
- Formula
- C11H15F3N4O2
- MW
- 292.26 g/mol
VQ-044671
![tert-Butyl 8-Oxo-3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazine-7(8H)-carboxylate chemical structure](/media/structures/MTMRRUGKAJDEEZ-UHFFFAOYSA-N.svg)
tert-Butyl 8-Oxo-3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazine-7(8H)-carboxylate
- CAS
- 877402-44-3
- Formula
- C11H13F3N4O3
- MW
- 306.24 g/mol
VQ-044672
FAQs — Sitagliptin impurities
Which Sitagliptin impurities do you supply?
We list 111 Sitagliptin-related reference materials, including process impurities, degradation products, stable-isotope-labelled standards and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Sitagliptin impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Sitagliptin impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Sitagliptin impurity standards
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